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mHealth Intervention to Prevent Postpartum Smoking Relapse

NCT ID: NCT04207827

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-02

Study Completion Date

2019-07-20

Brief Summary

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This project aims to develop an adapted and enhanced mHealth couple intervention to prevent post-partum smoking relapse.

Detailed Description

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The main goal of this project is to develop, implement, and disseminate effective and sustainable interventions to prevent and reduce smoking in families over their reproductive life span. So, the purpose of this project is to adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mHealth intervention. The scientific relevance of this research project is given by: 1) testing a cultural-adapted version of the iCoach mobile application for the prevention of smoking uptake after birth. 2) The cultural adaptation will be obtained based on the existing literature regarding the adaptation of preventive interventions for substance use. 3) The iCoach app intervention is enhanced with SMS-delivered content addressing the dyadic efficacy for smoking cessation aiming to improve both partners' skills to work together as a team to prevent smoking uptake after birth.

Conditions

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Tobacco Use Cessation Pregnancy Related

Keywords

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mHealth smoking postpartum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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xSmoker app

The xSmoker app was developed with European Commission funding. xSmoker is a digital health coaching mobile app that helps individuals stop smoking and remain smoke free. The initial version of the xSmoker application was received from the developers and translated into Romanian by the research team. The content has been divided into three main sections: "Daily Tips" (approximately 630 items), which includes information on the beneficial effects of quitting smoking, "Panic Tips" (approximately 100 items), which can be accessed at that time when risk of smoking relapse is high, as well as a section called "Library" (about 120 items), where detailed information on the topics included in the first two sections is provided.

Group Type EXPERIMENTAL

xSmoker app

Intervention Type BEHAVIORAL

xSmoker - mHealth intervention consisted of using the app xSmoker

xSmoker app + SMSs

The xSmoker app + phone text messages with content based on the Motivation and Problem Solving approach and informed by our prior work. The investigators developed six categories of messages sent to participants: (1)Importance and trust, (2)Fear of relapse, (3)Partner support, (4)Breastfeeding, (5)The need to smoke, and (6)Relapse. Four major objectives were established based on the content of the SMS text messages, with the help of the literature: (1)supporting motivation, (2)supporting self-efficacy, (3)supporting dyadic effectiveness, and (4)developing problem-solving skills. The messages were delivered using Textit, a platform for visually building interactive SMS applications (htpps://textit.in). All the messages were uploaded in the platform and different flows and sub-flows were created for every day of the intervention to automatize the process of SMS delivery. A combination of trigger words and skip patterns was used in order to tailor the messages.

Group Type EXPERIMENTAL

xSmoker app

Intervention Type BEHAVIORAL

xSmoker - mHealth intervention consisted of using the app xSmoker

SMS

Intervention Type BEHAVIORAL

Text messages with content based on the Motivation and Problem Solving approach and informed by our prior work.

Control

Usual postnatal care

Group Type OTHER

Usual Care

Intervention Type OTHER

Usual postnatal care

Interventions

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xSmoker app

xSmoker - mHealth intervention consisted of using the app xSmoker

Intervention Type BEHAVIORAL

SMS

Text messages with content based on the Motivation and Problem Solving approach and informed by our prior work.

Intervention Type BEHAVIORAL

Usual Care

Usual postnatal care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* older than 18 years
* gave up smoking 6 months before or during pregnancy
* owns a smartphone
* has a stable partner/husband
* offers the partner's contact data
* signs the informed consent
* CO level (ppm) below 4

Exclusion Criteria

* younger than 18 years
* smoker
* does not own a smartphone
* does not have a stable partner/husband
* refuses to offer the partner's contact data
* refuses to sign the informed consent
* refuses the CO level measurement or the CO level (ppm) is above 4
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Babes-Bolyai University

OTHER

Sponsor Role lead

Responsible Party

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Cristian Ioan Meghea

Project Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristian I Meghea, PhD

Role: PRINCIPAL_INVESTIGATOR

Babes-Bolyai University

Locations

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Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

Site Status

Countries

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Romania

Other Identifiers

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PN-III-P4-ID-PCE-2016-0632

Identifier Type: -

Identifier Source: org_study_id